Specified Drug Use-results Survey of Graceptor in Patients With Kidney Transplantation (Switching From Cyclosporine)

April 25, 2019 updated by: Astellas Pharma Inc

Specified Drug Use-Results Survey of Graceptor® Capsules 0.5mg, 1 mg, and 5 mg in Kidney Transplant Patients

To evaluate the safety and efficacy of Graceptor ® in patients with kidney transplantation when converted from cyclosporine

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

289

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Aichi, Japan
        • Site JP00001
      • Chiba, Japan
        • Site JP00015
      • Ehime, Japan
        • Site JP00003
      • Fukuoka, Japan
        • Site JP00029
      • Fukushima, Japan
        • Site JP00009
      • Gifu, Japan
        • Site JP00017
      • Hiroshima, Japan
        • Site JP00002
      • Hokkaido, Japan
        • Site JP00005
      • Hyogo, Japan
        • Site JP00024
      • Ibaraki, Japan
        • Site JP00012
      • Ishikawa, Japan
        • Site JP00020
      • Iwate, Japan
        • Site JP00010
      • Kagawa, Japan
        • Site JP00026
      • Kagoshima, Japan
        • Site JP00030
      • Kanagawa, Japan
        • Site JP00014
      • Kochi, Japan
        • Site JP00027
      • Kumamoto, Japan
        • Site JP00028
      • Kyoto, Japan
        • Site JP00008
      • Mie, Japan
        • Site JP00019
      • Miyagi, Japan
        • Site JP00011
      • Nagasaki, Japan
        • Site JP00006
      • Nara, Japan
        • Site JP00023
      • Niigata, Japan
        • Site JP00013
      • Okayama, Japan
        • Site JP00025
      • Osaka, Japan
        • Site JP00022
      • Saitama, Japan
        • Site JP00016
      • Shizuoka, Japan
        • Site JP00018
      • Tokyo, Japan
        • Site JP00007
      • Wakayama, Japan
        • Site JP00021
      • Yamagata, Japan
        • Site JP00004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are converted to Graceptor® from cyclosporine in the maintenance phase after kidney transplantation.

Description

Inclusion Criteria:

  • Patients who are converted to Graceptor® from cyclosporine in the maintenance phase after kidney transplantation.

  • Patients who meet one or more of following criteria

    1. Decrease in kidney function: GFR (or eGFR) less than 60 mL/min, or investigator's decision
    2. Hypertension: systolic/diastolic blood pressure 130/80 mmHg or more or treatment with an antihypertensive drug
    3. Hyperlipidaemia: LDL cholesterol 120 mg/dL or more, or treatment with an antihyperlipidemic drug
    4. Rejection: antibody mediated rejection by Banff classification borderline changes or more severe, or investigator's decision
    5. Other adverse events and patients who cannot continue cyclosporine treatment based on investigator's decision

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
patients with kidney transplantation who converted the immunosuppressant from cyclosporine to Graceptor ®
Drug: Graceptor®
oral
Other Names:
  • FK506
  • tacrolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of treatment continuation (incidence of rejection, death, graft loss, or adverse event)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Renal function, hypertension, hyperlipidaemia, other adverse events
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2013

Primary Completion (Actual)

March 31, 2016

Study Completion (Actual)

March 31, 2016

Study Registration Dates

First Submitted

June 9, 2014

First Submitted That Met QC Criteria

June 9, 2014

First Posted (Estimate)

June 10, 2014

Study Record Updates

Last Update Posted (Actual)

April 26, 2019

Last Update Submitted That Met QC Criteria

April 25, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRA006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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